DIN EN ISO 11608-5:2013

Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012); German version EN ISO 11608-5:2012

This part of ISO 11608 specifies requirements and test methods for needle-based injection systems with automated functions (referred to in the standard as NIS-AUTO), for the administration of medicinal products in humans.*This part of ISO 11608 specifies requirements and test methods for the following needle-based injection systems with automated functions (referred to in the standard as NIS-AUTO) for the administration of medicinal products in humans: - drug product preparation (for instance, reconstitution), - needle preparation, - air removal, - priming, - dose setting, - actuation, - needle insertion, - injection of the medicinal product, - needle retraction, - disabling the NIS-AUTO, - needle shielding or hiding (visual protection), - sharps injury protection, - needle removal. This document (FprEN ISO 11608-5:2011) has been prepared by Technical Committee ISO/TC 84 "Devices for administration of medicinal products and intravascular catheters" in collaboration with Technical Committee CEN/TC 205 "Non-active medical devices" (secretariat: DIN) and with the participation of German experts. At DIN, the German Institute of Standardization e. V., the responsible Working Committee is NA 063-02-01 AA "Injektionssysteme" ("Injection systems") at the Medical Standards Committee (NAMed).